Memorandum
Mylan provided its 4Q15 update yesterday in a call led by CEO Ms. Heather Bresch. There was no mention of the company’s Biocon-partnered biosimilar insulin glargine formulation, which is currently in phase 3 and should be submitted in the US and EU in 2H16 – that’s pretty soon! The majority of the call focused on Mylan’s recent $7.2 billion acquisition of Swedish pharmaceutical company Meda; management did note that the deal should help Mylan expand its presence in emerging markets in areas including insulin. We see this as a positive since such a low percentage of patients in developing countries take insulin though many things must go right in order for a thriving commercial market for biosimilar insulin to develop. As a reminder, in Biocon’s F3Q16 update last month, management predicted that 2016 would be a “very exciting year” for the biosimilar glargine. Biocon reiterated that the companies intend to submit the product through the 505(b)(2) pathway in the US and to pursue an interchangeable designation. Biocon also cited Mylan’s vast experience in the generic market as a key asset that should allow the companies to compete with Lilly/BI’s Basaglar/Abasaglar even if they do not achieve interchangeability. The next couple of years should finally provide clearer answers on the main questions surrounding biosimilar insulins, particularly those related to price and perception of safety. See our coverage of Dr. Philip Home’s (Newcastle University, Newcastle upon Tyne, UK) comprehensive talk on biosimilars at ATTD for more insights on this developing area.